Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Wednesday, October 17, 2018 Daily Archives

The former Imclone facility will be knocked down to give Eli Lilly “flexibility for future opportunities” at its Branchburg, New Jersey site, the firm says. Building 36 on Eli Lilly’s Branchburg, New Jersey campus is scheduled to be demolished by the end of the first quarter of 2019, Lilly spokesperson Tamara Ann Hull told BioProcess Insider. “A second building on the same campus – a new, higher capacity, modern facility, Building 50 – has been producing biologics since 2006. Therefore,…

Symbiosis has received US FDA approval for viral vector manufacturing fill/finish at its biomanufacturing facility in Stirling, UK. In this Q&A, CEO Colin MacKay explains the significance of the accreditation with regards to industry demand and Brexit. Scottish contract development and manufacturing organization (CDMO) Symbiosis Pharmaceutical Services constructed its sterile manufacturing facility in 2011 and has had UK regulatory accreditation since 2012. The firm recently received approval from the US Food and Drug Administration (FDA), something CEO Colin MacKay told…